FDA 510(k) Applications for Medical Device Product Code "LFY"
(Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster)

FDA 510(k) Number Applicant Device Name Decision Date
K923122 BIOMERIEUX VITEK, INC. VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM 10/26/1992
K833637 BIONETIC LABORATORY PRODUCTS VZV BIO-ENZABEAD SCREEN KIT 02/10/1984
K943843 BIOWHITTAKER MOLECULAR APPLICATIONS, INC. VARICELISA, MODIFICATION 03/14/1996
K900688 CLINICAL SCIENCES, INC. VARICELLA ZOSTER IGG CLIN-ELISA TEST KIT 05/15/1990
K981867 DIAMEDIX CORP. IS-VZU IGG TEST SYSTEM 09/28/1998
K890642 DIAMEDIX CORP. VZV MICROASSAY 05/15/1989
K150375 DiaSorin Inc. LIAISON VZV IgG, LIAISON Control VZV IgG 03/11/2015
K061820 DIASORIN, INC. DIASORIN LIAISON VZV IGG 02/26/2007
K941046 GULL LABORATORIES, INC. VZV IGG ELISA TEST 08/24/1995
K823805 M.A. BIOPRODUCTS VARICELISA TEST KIT 05/05/1983
K914022 PHARMACIA DIAGNOSTICS, INC. SERIOLOGICAL TEST KIT/IGM ANTIBODY VARI-ZOST VIRUS 01/27/1992
K972295 QUEST INTL., INC. SERAQUEST VZV IGG 11/05/1997
K984181 ZEUS SCIENTIFIC, INC. THE APTUS (AUTOMATED) APPLICATION OF THE VZV IGG ELISA TEST SYSTEM 01/22/1999
K961012 ZEUS SCIENTIFIC, INC. VZV IGG ELISA TEST SYSTEM 07/24/1996
K070317 ZEUS SCIENTIFIC, INC. ZEUS SCIENTIFIC, INC VZV IGM ELISA TEST SYSTEM 07/05/2007
K051484 ZEUS SCIENTIFIC, INC. ZEUS SCIENTIFIC, INC., ATHENA MULTI-LYTE MMRV IGG TEST SYSTEM. 12/05/2005


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